University Policy on Conflicts of Interest
A. POLICY STATEMENT1
1.
This document sets forth University, Nevada System of Higher Education Board of Regents,
State and Federal requirements to identify, manage, reduce and/or eliminate conflicts of interest.
The key to conflict of interest management is timely and appropriate disclosure by University
Employees who shall disclose any outside activity or interest that may adversely affect,
compromise, or be incompatible with the obligations of the Employee to the University or to
widely recognize professional norms as defined herein. Employees shall disclose all potential
conflicts held by the Employee or the Employee’s Household or Family Members that the
Employee knew or should have known. Such disclosure shall be made on an annual basis by
Faculty and Key Personnel and on a project basis as necessary for other employees. Potential
conflicts of interest, when properly disclosed and managed, can serve to benefit the University, the
State of Nevada, and the Nation. This document prescribes procedures for disclosure, review, and
for the exercise of ongoing oversight of potential and/or actual conflicts where necessary. It also
provides for review of decisions at higher levels of University administration. Lastly, it
indicates the sanctions that may be applied when the policy is violated.
B. PURPOSE AND SCOPE1
1. In carrying out its primary missions of teaching, research and service, the University must
implement a diverse set of principles: maintaining academic freedom and an atmosphere that
promotes free and open scholarly inquiry without bias; facilitating the transfer of technology and
other developments for the benefit of the public; and serving as the steward of public and private
resources entrusted to it. There are several general categories of Conflict of Interest that this policy
will address: Research and Other Sponsored Projects, Use of University Resources, Technology
Transfer and Commercial Endeavors, and Institutional Conflict of Interest. The University
recognizes the value of transferring technology and other activities to enhance public access to
University research and to further the economic development of the State and the Nation.
Additionally, participation by academic and administrative faculty, staff and students in external
activities that enhance their professional skills or constitute public service may be beneficial to the
University as well as the individual. As the institution grows and develops relationships with
federal, state, and private institutions, the potential for conflicts of interest increases. These
conflicts, when properly disclosed and managed can serve to benefit the institution, and spur
economic development and diversity for the state of Nevada and its citizens. The primary goal of
this policy is to provide a means to manage potential conflicts to enhance the benefit to the
public and reduce or eliminate the costs and perceived negative outcomes that such potential
conflicts may carry.
1
This policy overlaps with but does not supplant University Employees' responsibilities under the Nevada Ethics
in Government Law, NRS 281.411,, which in some instances may include additional reporting
responsibilities. In many instances, this policy is broader than the Ethics Act in the situations covered. Also,
incorporated by reference are the NSHE Board of Regents Handbook; UNR administrative manual; the National
Science Foundation Policy; Grant Policy Manual 510, Investigator Disclosure Policy, 60 F.R. 132, pp. 35810-823
(July 11, 1995) and U.S. Department of Health and Human Services, Objectivity in Research Subpart FResponsibility of Applicants for Prompting Objectivity in Research for Which Funding is Sought, 42 CFR Part
50, Subpart F. As additional external federal policies are imposed, or if project specific requirements are imposed
by a federal or state sponsor, this policy will incorporate such new policies by reference. In all events, adherence
to the most restrictive policy is required.
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2. To this end, it is critical that business transactions and the design, conduct or reporting of
research will not be biased or compromised by any conflicting financial interest or other potential
or actual personal gain of an Investigator or the University or one of its units. Failure to
comply may jeopardize existing or future funding, and erode public trust. The University
recognizes that many potential conflicts of interest do not constitute actual conflicts or may be
acceptable with proper oversight and safeguards. The complexity and diversity of professional
relationships has grown increasingly intertwined with outside entities in research and other
University activities. Increased research support from private entities, changes in federal law and
regulations encouraging technology transfer and the need for the University and its Employees to
demonstrate public accountability mandate new approaches in the discovery and management of
potential conflict of interest situations. This may require reevaluation of previously acceptable
activities. The most effective way to address conflict of interest is to establish a process by
which Employees disclose and obtain evaluation of potential conflict on a case by case basis.
C. APPLICABILITY
1. This policy applies to all University Employees. As appropriate, subcontractors and other
external collaborators must also comply with this policy unless their institution/company provides
adequate assurances that they are in compliance with the federal regulations referenced below.
This policy applies to any research, education or service activity regardless of whether or not
support is provided to the University or Employee. Support may be in the form of sponsorship,
pecuniary incentive, equipment or gift.
2. Conflicts also arise in procurement situations when an Employee has the option of purchasing
goods or services from entities in which the Employee has a substantial financial or other interest.
Procurement conflicts are treated separately in the NSHE Business Center North Purchasing
Policies and Procedures and are not within the scope of this policy. However, because conflict
of interest situations covered by this policy may also involve procurement issues, the Conflicts of
Interest Committee will, from time to time, need to coordinate their efforts with the Director of
Purchasing.
D. DEFINITIONS
1. “Business Entity” means a sole proprietorship, partnership, association, joint venture,
corporation, firm, trust, foundation, or other organization or entity used in carrying on a
trade or business, including parent organizations of such entities or any other arrangement in
which an entity operates through a subsidiary.
2. “Clinical Investigations” include any research project dealing with humans, including
medical industry corporation or other private business entity sponsored trials, departmental
sponsored research, studies utilizing human tissues, social science research, and medical chart
reviews.
3. “Conflict of Commitment” may occur when external activities demand excessive time,
conflicting with an Employee’s responsibilities to the University, or when external activities result
in direct competition with University activities.
4. “Conflict of Interest” means any outside activity or interest that may adversely affect,
compromise, or be incompatible with the obligations of an Employee to the University or to
widely recognized professional norms. A significant conflict of interest includes, but is not limited
to, situations where consideration of a significant financial or other interests will likely affect the
approval, design, conduct, or reporting of research or other projects or the objectivity of decision
making as an Employee of the University.
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5. “Designated Official” is the person responsible for reviewing all financial disclosures and
will review situation information and advise the Conflict of Interest Committee as to whether a
conflict of interest exists. The designated official shall be appointed by the President of the
University. This individual may change from time to time upon designation by the President.
6. “A Domestic Partnership” is a legally recognized relationship between two people that confers
nearly all the same rights and responsibilities under state law as marriage. A domestic partnership is
created by registering with the Nevada Secretary of State.
7. “Employee” means any person who is employed by the University of Nevada, Reno, whether full
or part time, and includes but is not limited to staff, faculty, postdoctoral appointees, residents
and student Employees. It also includes Investigators as defined by the federal policies referenced
below and individuals who are not paid on a project (i.e., “volunteers”).
8. “Faculty and Key Personnel” include individuals who are engaged at least 0.5 FTE as a
faculty member and/or who serve as a Principal or Co-Principal Investigator on research or other
projects and who are involved in the design, conduct, execution, reporting or fiscal oversight of
University or externally funded projects and/or individuals who are determined to be Inventors of
Intellectual Property by use of University resources.
9. “Family Member” means spouse and any other persons such a domestic partner , child,
parent, sibling or other family member claimed on the Employee’s tax return.
10. “Household Members” means an association of persons who live in the same home or
dwelling, sharing its expenses, and who are related by blood, adoption or marriage.
11. “Institutional Conflict of Interest” refers to situations where the University’s beneficial
relationship with corporate entities may place it in conflict with its responsibilities as a public
institution of higher education. The conflict may involve equity interest in companies, certain
licensing situations, and Board and other leadership positions held by University faculty or
administrators.
12. “Intellectual Property” means any ideas, inventions, technology, creative expression and
embodiments thereof, in which a proprietary interest may be claimed, including but not limited to,
patents, copyrights, trademarks, know-how, and biological materials. This policy is intended to
affect only that Intellectual Property owned by the University. It does not alter other University
policies that determine ownership of Intellectual Property.
13. “Investigator” includes any faculty, staff, postdoctoral fellow, resident or student who is
responsible for the design, conduct or reporting of research or scholarly activities conducted in
whole or in part at the University of Nevada, Reno.
14. “Personal Gain” includes gifts and other incentives to Investigators, their University departments,
or other University entity, or immediate family members.
15. “Public Health Service (PHS)” means the Public Health Service of the U.S. Department of Health
and Human Services, and any components of the PHS to which the authority of the PHS may be
delegated. The components of the PHS include, but are not limited to, the Administration for
Children and Families, Administration on Aging, Agency for Healthcare Research and Quality,
Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention,
Federal Occupational Health, Food and Drug Administration, Health Resources and Services
Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and
Mental Health Services Administration.
16. “Research Agreements” may
include testing agreements, service agreements,
collaborative agreements, clinical investigation agreements, purchase orders, material transfer
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agreements, confidentiality agreements and any other written agreement between the University
and an external entity that has been duly signed and agreed upon by authorized officials of the
cooperating entities.
17. “Significant financial interest” means:
(1) A financial interest consisting of one or more of the following interests of the Investigator (and
those of the Investigator's spouse and dependent children) that reasonably appears to be related to
the Investigator's institutional responsibilities:
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of
any remuneration received from the entity in the twelve months preceding the disclosure
and the value of any equity interest in the entity as of the date of disclosure, when
aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary
and any payment for services not otherwise identified as salary (e.g., consulting fees,
honoraria, paid authorship); equity interest includes any stock, stock option, or other
ownership interest, as determined through reference to public prices or other reasonable
measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the
value of any remuneration received from the entity in the twelve months preceding the
disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's
spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other
ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income
related to such rights and interests.
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel ( i.e., that
which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact
monetary value may not be readily available), related to their institutional responsibilities;
provided, however, that this disclosure requirement does not apply to travel that is reimbursed or
sponsored by a Federal, state, or local government agency, an institution of higher education as
defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research
institute that is affiliated with an Institution of higher education. The Institution's Conflict of
Interest (COI) policy will specify the details of this disclosure, which will include, at a minimum,
the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In
accordance with the Institution's COI policy, the institutional official(s) will determine if further
information is needed, including a determination or disclosure of monetary value, in order to
determine whether the travel constitutes a COI with the Public Health Services (PHS) funded
research.
(3) The term significant financial interest does not include the following types of financial interests:
salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator
is currently employed or otherwise appointed by the Institution, including intellectual property
rights assigned to the Institution and agreements to share in royalties related to such rights; any
ownership interest in the institution held by the Investigator, if the Institution is a commercial or
for-profit organization; income from investment vehicles, such as mutual funds and retirement
accounts, as long as the Investigator does not directly control the investment decisions made in
these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal,
state, or local government agency, an Institution of higher education as defined at 20 U.S.C.
1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated
with an Institution of higher education; or income from service on advisory committees or review
panels for a Federal, state, or local government agency, an Institution of higher education as defined
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at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is
affiliated with an Institution of higher education.
Small Business Innovation Research (SBIR) Program means the extramural research program for
small businesses that is established by the Awarding Components of the Public Health Service and
certain other Federal agencies under Public Law 97–219, the Small Business Innovation
Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes
the Small Business Technology Transfer (STTR) Program, which was established by Public Law
102–564.
18. “Technology Transfer” includes any option, license, assignment, or conveyance of any other legal
or equitable interest in Intellectual Property owned by the University, including but not limited to
the right to make, market, copy, sell, or use such property in any way.
19. “Travel Expenses” reflect travel paid for or reimbursed from a business entity, excluding travel
reimbursed by a government agency, an academic teaching hospital or medical center or a research
institute that is affiliated with an institution of higher education.
E. CONFLICT OF INTEREST SITUATIONS
1. The issues addressed in this section include situations that constitute a Conflict of Interest and
require full disclosure. Approved conflicts of interest require oversight by the University and
may require modification to reduce or eliminate the conflict. Certain activities present an
unacceptable Conflict of Interest that the University will not allow under any circumstances (See
Section G below).
a. Use of University Property or Facilities.
1. Employees shall not use NSHE time, property, equipment, or other facility to benefit
their personal or financial interest.2 However, as provided in NRS 281.481(7), limited use
for personal purposes is allowable if the use does not interfere with the performance of an
employee’s duties, the cost and value related to the use is nominal, and the use does
not create the appearance of impropriety of NSHE endorsement. Personal use shall not
interfere with official institutional use. Personal use of NSHE time, property, equipment,
or other facility must be approved in advance by the employee’s supervisor. If the
institution or unit incurs a cost as a result of a use that is authorized pursuant to this policy
or would ordinarily charge a member of the public for the use, the employee shall
promptly reimburse the cost or pay the charge. An employee who intentionally or
negligently damages NSHE property, equipment, or other facility shall be held responsible
for the resultant expense.
2. Except as otherwise approved pursuant to this or other University policy or agreement, use
of University facilities and equipment resulting in identifiable costs to the
University REQUIRES APPROVAL by the Provost. Approval of such situations may
be granted in exceptional circumstances conditioned upon reimbursement of costs. Only
the President may grant exceptions to the requirement for reimbursement.
2
NSHE Code; Title 4, Chapter 1, Section 25
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b. Conflict of Interest Involving Students.3
Research agreements with external sponsors,
especially entities in which an Investigator has a financial, managerial or executive relationship
must maintain basic academic values and promote open dissemination of knowledge. Student
participation in such activities is of particular concern. It is important that the educational
experience of students and postdoctoral fellows not be influenced detrimentally by faculty
special interests or relationships with external funding entities. Consistent with these policies
and concerns, the following projects require APPROVAL before they are commenced and
MONITORING throughout:
1. Projects of a confidential nature that include restrictions of student publication or
communication rights with respect to research or other work that will be the basis of
evaluation of the student or fulfillment of degree requirements. Such projects will only be
permitted if the publication restrictions are reasonably necessary to protect intellectual
property rights and do not prevent the publication of student research in a timely manner.
Publication in a timely manner shall usually be the earlier of 60 days from the completion of
the project or the completion of the student’s degree requirements.
2. Sponsored research projects involving students that have the potential to substantially
benefit a business entity in which a faculty member has a significant financial or other
interest. Approval shall be granted only where there is a demonstration that students will
receive some academic benefit from their efforts without risk to academic freedom,
integrity and objectivity.
Approval shall not be granted where such research is
motivated primarily by commercial concerns and will be the basis of evaluation of the
student or fulfillment of degree requirements.
3. Sponsored research projects where a student is both working on a project for a
faculty member at the University and working at a company in which the faculty member
has a financial or other interest.
4. Sponsored research where the research is driven primarily by commercial considerations and
the sponsor is involved in the direction of the research.
c. Interactions with Private Enterprise.4 All of the examples described in this section have
the potential for appearance of, and actual, misallocation of resources. Each situation requires
APPROVAL AND MONITORING. Approval normally should be based on the proponent
demonstrating that the activity significantly benefits the University and its public mission
and does not involve an unacceptable risk of misallocation of funds and other resources or
breach of the University’s integrity. Approvals will be conditioned on technical and financial
oversight of the project and any related activities, as well as reimbursement of all costs for
uses of University resources that primarily benefit private entities.
1. Research projects where an Employee also has direct or indirect authority over expenditure
of funds and where the research is sponsored by a business entity in which the
Employee or his/her Household or Family Members have a significant financial or other
interest.
3
This section is not intended to preclude the involvement of research assistants or research associates who are
primarily University Employees in support of commercial activities or work that will not be used for evaluation of a
student or fulfillment of degree requirements, under arrangements otherwise consistent with this and other
University policies
4
The procurement of general goods and services from private enterprises can create significant potential conflicts
of interest. Procurement conflicts are specifically addressed in the Board of Regents Handbook, Title 4, Chapter
10, Section 1 (7) and are not within the purpose and scope of this policy. However, because conflict situations
covered by this policy may also involve procurement issues, this policy and the Board of Regents Handbook
policy may both apply.
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2. Reimbursed use of faculty, students, research associates, technicians or other staff
supported by public funds for work motivated primarily by commercial concerns or
intended to benefit a business entity in which an involved Employee or his/her Household
or Family Members have a significant financial or other interest.
3. Participation by an Employee in a University decision that has the potential to benefit
significantly or injure, directly or indirectly, a business entity in which the Employee
or his/her Household or Family Members have a significant financial or other interest.
The preferred procedure will normally be for the Employee to withdraw from participation
in the decision. In no event should the Employee be the final decision maker.
4. Use of University or other public or private funds for expenditures that have the potential
to benefit a business entity significantly in which an Employee or his/her Household or
Family Members have a significant financial or other interest. One example of this
situation is the purchase of equipment that may be useful to a business for which the
Employee consults, or in which an Employee has an ownership interest. Another
example of this situation is a project involving testing of a product in which an Employee
has a significant financial or other interest, or a product that is a competitor of a product in
which the Employee has a significant financial or other interest.
5. Transfer of University technology or other Intellectual Property to a business entity in
which the University Employee inventor or his/her Household or Family Member has a
significant financial or other interest.
6. Clinician referrals to a business entity in which the clinician/ Employee or his/her
Household or Family Member has a significant financial or other interest unless such
referral is otherwise authorized under the University of Nevada School of Medicine
physician practice plan.
7. Submission of proposals and acceptance of awards for grants or contracts by, to or from a
business entity in which an involved Employee or his/her Household or Family Member
has a significant financial or other interest, where the subject matter of the grant proposal is
substantially related to the Employee’s University research and where the University is
qualified and eligible to apply.
F. CLINICAL RESEARCH
1. It is critically important for the University to manage conflicts in the area of Clinical
Investigations due to the ethical requirement for protection of research participants and the general
public. Financial or other personal gain interests of the Investigators, their Household or Family
Members, the University, or units of the University must not influence, or appear to influence, the
approval, design, conduct or reporting of research or any clinical trials involving the evaluation of
products such as drugs or medical devices or procedures. It is of the utmost importance that
personal gains b y a n y m e m b e r o f t h e c l i n i c a l r e s e a r c h t e a m n o t i n f l u e n c e the
consent process such that participation is encouraged by even subtle minimization of the risks and
exaggeration of the benefits to the potential subject. Additionally, arrangements with corporate
sponsors which include recruitment bonuses, time designated accrual incentives, or finder-fees may
influence the consent process, the reporting of adverse events, or the analysis of the data, thereby
creating conflicts which must be disclosed and reviewed. For these reasons, the following
policies apply to all Clinical Research projects at the University:
a. Prior to each study involving human subjects, all aspects of financial relationships
between members of the investigative team, their Household or Family Members, the
University and its entities, and the corporate sponsor must be DISCLOSED. These include
commitments of financial support unrelated to the current study, financial incentives,
payments as a consultant, and non-monetary rewards and incentives to Investigators and their
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b.
c.
d.
e.
f.
Household or Family Members, including travel, entertainment and gifts.
Clinical research projects sponsored by business entities where Investigators, other Employees,
or their Household or Family Members, or University units, have significant financial or other
interests require APPROVAL and MONITORING. Employees with significant conflicts
may participate as an Investigator or key personnel only under exceptional circumstances.
Under no circumstances shall a conflicted Employee obtain consent from subjects for their
participation in a research project. At the time of a new study submission and at the time of
continuing review, the IRB will evaluate how the management plan suggested by the Conflict
of Interest committee affects the conduct of the research or research subjects. In that review,
the IRB will determine if the proposed management plan needs to be modified to protect the
research subjects.
All studies of human subjects REQUIRE APPROVAL from the Institutional Review Board
(IRB) with additional assurance from the Investigators that there are no personal conflicts that
may threaten the safety and privacy interests of the patient/research subject and public trust of
the University’s integrity and credibility
Any financial or other interest that an Investigator, his/her Household or Family Member, or a
unit of the University, have in a business entity sponsoring a clinical investigation must be
DISCLOSED to the subjects recruited into the study.
Sponsors of human research may provide payments or incentives related to a specific study
by depositing into a departmental account. Employees with a financial or other interest in the
sponsoring entity should not have signatory privileges on this account for disbursement of
funds. Individual Employees involved in a study may not themselves or on behalf of their
Household or Family Members, accept payments, incentives or gifts from sponsors of clinical
research.
Training will be required for all Investigators receiving PHS funding on the Financial Conflict
of Interest Policy and federal regulations, specifically the Investigator’s responsibilities
regarding disclosure of significant financial interest (SFI) and the regulations, prior to engaging
in funded research at least once every four years.
G. ACTIVITIES THAT ARE NOT ALLOWED5
1. The following activities present conflicts of interest that cannot properly or effectively be
approved and monitored and, therefore, are NOT ALLOWED.
a. Solicitation or Receipt of Gifts.
1. Solicitation or receipt by a University Employee or his/her department of a gift
(including money, non-pecuniary gifts, excessive compensation or non-commercial loans)
where
i)
The purpose or effect of the gift is likely to influence the Employee in the
discharge of his/her University responsibilities (i.e., vendor selection);
ii)
The gift is given to reward the Employee for official action taken; or
iii)
The gift is given in close proximity to recent past, present or future
transactions between the University and the giver of the gift.
5
NOTE: A University Employee advising a government agency on matters in which the Employee has a
significant financial or other interest, evaluating commercial competitors for a government agency, or consulting
for a federal agency while conducting research sponsored by the agency, may be subject to agency conflicts of
interest policies and disclosure requirements. Employees should remember that such requirements exist separate
from and in addition to University’s requirements.
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2. This section is not intended to apply to the regular or ordinary compensation an
Employee receives from a business entity in situations covered above by Section E.1.c,
where approvals have been granted. This section also does not apply to occasional nonpecuniary gifts that have an insignificant monetary value and would not tend to influence
an Employee in the discharge of his/her duties.
b. Evaluation or Arrangements that interfere with analysis
1. Secrecy or confidentiality requirements beyond the scope of Section E.1.b on projects
that will be the basis of evaluation of a student or fulfillment of degree
requirements, or evaluation of faculty or other Employees.
2. Arrangements that permit sponsor interference with the scientific analysis or publication
of research results or conclusions.
3. Evaluation of faculty, postdoctoral fellows, staff, or students based on participation in
(or refusal to participate in) outside activities involving business entities in which the
evaluating Employee or his/her Household or Family Member have a significant financial
or other interest. The involved Employee shall not participate in such evaluations.
c. Conflicts Associated with University Employees and Private Enterprise.
1. Non-reimbursed involvement of faculty, students, research associates, technicians, or
other staff supported by public funds, on University time, for work motivated primarily by
commercial concerns or intended to benefit a business entity. Such involvement must
be disclosed and the University resources utilized must be fully compensated by the
commercial entity through a negotiated contract in accordance with the Board of Regents
Policy.
2. Physician consultation for the purpose of marketing a product for a medical product
company when the physician/researcher is in receipt of a grant or contract from the
same company.
3. Obtaining consent of subjects by Employees who themselves, or whose Household or
Family Member members, have financial or other interests in an entity sponsoring the
clinical research.
4. Conflicts between an Employee’s obligations to the University and his/her commitments
to an outside entity, including a sponsor of University-based research. For example, an
Employee may not have an agreement with a sponsor regarding transfer of technology
or Intellectual Property in conflict with the University policy governing
ownership of Intellectual Property.
5. Transfer of University technology or other Intellectual Property without following the
University’s patent and copyright policies.
6. Use of the University’s name in connection with private activities in a manner that
inappropriately suggests that the University endorses, sponsors or approves of such
activities or views of the Employee.
7. Use of the University’s facilities, equipment, property, or personnel by an outside entity
in which an Employee has a significant financial interest. Unless the entity has an
agreement for lease or use of such space, equipment property or personnel signed by an
institutional official with signature authority for the institution.
8. Receipt of publisher incentive fees by an Employee who has authority to require
educational materials for students involved in specific coursework at the University. This
provision does not preclude royalty payments to authors of educational materials used by
students in their coursework.
9. Sponsored Agreements or sub-agreements between the University and an organization
where an Employee or his/her Household or Family Members has a significant financial
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interest which do not fully reimburse the University for use of facilities, personnel,
equipment, space or other resources including full payment of University overhead and
other rates for such use.
H. CONFLICT OF COMMITMENT6
1. Conflict of Commitment may occur when external activities, including consulting and other
professional or personal activities, compete with an Employee’s responsibilities to the University
and detract from the mission of the University. All University personnel holding full-time7
positions shall give full service to University work during scheduled work periods. Any nonUniversity employment must not interfere with the discharge of the person’s full-time service
obligations to the University. Full-time University Employees will treat the University as their
prime employment activity.
2. Part-time or full-time employment in an off-campus position or business enterprise in addition to
full- time University employment is discouraged unless such off campus employment is
considered to improve upon or facilitate the Employee’s teaching or other University duties. Each
faculty member or classified staff member is responsible to inform his/her immediate superior
of all such outside employment activities.
a. Public Service.
The University approves of public service activities that are not
incompatible with full performance of University duties and not inconsistent with University
policies and procedures.
b. Outside Teaching. Academic Faculty members may not accept employment for, and may
not perform, any teaching, instructional, or research services for other academic institutions
during teaching semesters without the knowledge and written approval of the cognizant chair
and dean. Compensated or uncompensated participation in an occasional short-term conference,
seminar, or symposium or the delivery of a scholarly paper or public address at a
professional meeting or academic gathering under the auspices of an academic institution, does
not violate this policy.
c. Public Addresses. Requests for faculty or staff members to give addresses to clubs,
community organizations, and other groups may be responded to at the discretion of each
individual faculty or staff member. Such activities shall not interfere with the faculty or staff
member’s University responsibilities.
d. Medical Faculty Consultations. Full-time medical faculty may not engage in private practice
or consultation work except in conformity with the School of Medicine Practice Plan or
other policies approved by the president, upon recommendation by the Dean of the Medical
School, subject to such conditions and limitations as the president may require. Such medical
practice or consultation work must not interfere with the faculty member’s primary
responsibility to the University.
6
This section incorporates the consultant policy and use of University resources policies located in the
University Administrative Manual.
7
Full-time - An employment relationship, applicable to both faculty and classified Employees, which requires
a commitment of 100% of the individual's normal and expected working time and effort. Full-time employment
is generally inconsistent with the acceptance of any other employment on a continuous or permanent basis.
However, such activities may be acceptable with Department Chair or appropriate supervisor permission. In the
event the employment poses a potential significant financial conflict or conflict of commitment, such
potential conflicts should be disclosed to the University under the processes defined in this policy. Also refer to
the Board of Regents Handbook, Title 4, Chapter 3, Section 8.
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e. Consultation. Consultation and other services to persons, firms, institutions, and agencies
outside the University may be carried on by University Employees so long as the performance
of such services does not interfere with the individual’s obligations to the University, subject to
the following restrictions:
1. Faculty members are allowed to be compensated for outside professional or scholarly
activities providing they comply with the Board of Regents’ policy, Title 4, Chapter
3, Section 8 of the Board of Regents Handbook. Compensated outside professional service
by faculty members is a legitimate activity unless specifically prohibited by the employee’s
contract with the University.
2. Use of consultation time should have a demonstrable relation to the professional interests
of the faculty member or administrative officer, and to the University’s general mission
within the community.
3. Consultation involving service to individual patients or clients may take place in a faculty
or staff member’s office. Other than limited use8 of University facilities and/or equipment
for non-University supported purposes must comply with the University Policy on the
Use of University Space and Equipment. When authorized by the Provost or the Provost’s
designee, use of University space or equipment shall be reimbursed on a full
overhead basis. Intellectual property rights developed using significant University
resources shall be negotiated with the University in accordance with the University’s
Intellectual Property Policy.
4. The individual engaged in consultation activities must arrange in advance, with the
approval of the responsible department chairperson, director, or other line officer, for
scheduling of classes or other work assignments missed as the result of consultation
activities.
5. Individual exceptions to this policy may be approved by the cognizant vice president
upon recommendation of the dean or director, subject to any specific conditions imposed
by the President.
f. Responsibilities of Consultants. University Employees engaged in consultation services have
the following responsibilities:
1. The University Employee must advise, in writing, the person, firm, or agency for whom
such consultation services are to be performed using language as specified in Sections i
and ii below that
i)
The Employee, in his/her role as a consultant, is acting solely as an
independent contractor, and not as an agent or Employee, or under the
sponsorship, auspices, or control of the University of Nevada, Reno; and
ii)
The University assumes no responsibility whatever, express or implied, for the
actions or omissions of the Employee in his/her role as a consultant.
2. The University Employee must personally assure that the conditions and limitations
upon external consulting activities, as required by University policy, are fully satisfied,
and must be prepared to document that fact if called upon to do so by a responsible
University officer.
8
Limited use is defined by NRS 281 481, subsection 7 - - The use does not interfere with the performance of
his public duties; the cost or value related to the use is nominal; and t h e use does not create the appearance of
impropriety. Nominal use includes the use of mailing lists, computer data or other information lawfully
obtained from a governmental agency which is available to members of the general public for nongovernmental
purposes; or the use of telephones or other means of communication if there is not a special charge for that use.
July 2012
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3. Before entering into a consultation contract, the University Employee must personally
determine that the contemplated consultation activities and arrangements will not involve a
Conflict of Interest with the individual’s duties to the University that may be in violation
of this policy. Such conflicts may be implicated if:
i)
ii)
iii)
I.
The consultant is or will be serving concurrently as a principal investigator under
a contract or grant from the same external firm or agency; or
The consultant’s services are directly related to and derived from activities
performed under a contract or grant from the same external firm or agency, or from
confidential information acquired as a result of participation in such a contract or
grant; or
The consultant agreement anticipates the use or development of intellectual
property in the same field or scope of work that the consultant provides to the
University as an Employee and/or the agreement contemplates assignment of rights
to such intellectual property.
INSTITUTIONAL CONFLICT
1. The University must also avoid and/or manage Conflict of Interest positions where its beneficial
relationship with corporate entities may place it in conflict with its responsibilities as a public
institution.
2. General Principles.
a. The University will deal legally and ethically with external sponsors of research and
sponsored programs in ways that avoid institutional conflicts of interest.
b. The University will not enter into agreements contrary to its mission.
c. The University will not accept an award for a project that is unacceptable to the
principal investigator. Once an award is accepted by the University, all parties are expected to
fulfill their obligations under that agreement.
d. The University will not enter into activities or agreements which could jeopardize its eligibility
to receive federal or state funds.
3. Equity Interest in Corporations: Investment in Research.
a. Of particular concern are research activities (the design, conduct, or reporting of research
results) where the University of Nevada, Reno Foundation or Research Ventures, Inc. has
equity in a business or receives donations from a business sponsoring research. These
situations may create conflicts, or the appearance of conflict, that compete with those of
research Investigators or in the case of clinical research, of the research subject. Any
financial relationship with a corporate sponsor should be documented, and include the
following: equity interest or ownership, payments to the University or a unit of the University
beyond payments directly associated with costs to carry out a particular protocol or scope of
work, any funds or other items of value given to the University or a unit thereof, any percent
ownership of patents, royalties, or licenses granted to the commercial sponsor by the
University, and whether or not the University stands to gain financially if the study shows
a positive outcome.
b. Before entering into business agreements that may place the institution in a Conflict of
Interest situation, the University shall ask the Conflict of Interest Committee to review and
recommend strategies for management of the conflict. Similar reviews shall be made of all
active previous business arrangements, and where conflicts are found, referred to the Conflict
of Interest Committee for review. The process to reduce, manage or eliminate such research
July 2012
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conflicts that the institution may have, will be handled by the Conflict of Interest
Committee and managed similarly to an individual Conflict of Interest situation. The Conflict
of Interest Committee that oversees institutional conflicts will include a minimum of two nonUniversity affiliated individuals. Possible solutions may include special management to protect
the scientific integrity of the study and in the case of clinical research management to
assure the safety of research participants, or alternatively, having a clinical study performed at
other sites.
4.
Administrative Decision Making by Individuals Who have Personal Conflicts of Interest
a. All University Employees participating in decision making related to the design, conduct or the
reporting of research should be aware and comply with Conflict of Interest principles,
including those stated above. This includes when they are involved in personnel decisions,
overseeing compliance activities, assigning space, selecting purchasing contracts, and other
issues in which their personal Financial Interests may be perceived to bias their decision
making regarding the research activity.
J. CONFLICT OF INTEREST COMMITTEE AND DECISION MAKING
1. Conflicts of Interest Committee.
a. The Conflicts of Interest Committee shall be a standing committee appointed by the
President (the “Committee”). The Designated Official will be appointed by the President. The
Committee shall be chaired by a faculty member nominated by the Faculty Senate and
approved by the President. The Chair shall serve a three year term. The Committee shall
be comprised of 5 voting members composed of members from academic units. Each
member will serve a three year term. The members will be appointed by the dean to
whom the individual reports. Preferably, the academic unit (that the proposed member
reports) will be involved in research activities and recipient at some level with Public
Health Service funding.
The following ex officio members: Director, Office of
Sponsored Projects, Dean of Graduate School, Director, Technology Transfer Office,
Director, Research Integrity/COI Designated Official, and Associate Vice President for
Research, COI Committee Representative School of Medicine and Associate Vice
President, Business and Finance are non-voting members of the committee. The
Designated Official shall attend Committee Meetings to provide advice and direction. If
appropriate, based on the nature of the Conflict of Interest disclosure, the Committee may
request the presence of the Director of Purchasing, the NSHE Office of General Counsel or
other faculty members, deans, chairs and/or directors to assist in the committee process. A
quorum consists of over half of all voting members. The Committee shall serve as an advisory
body to the University administration on conflicts of interest issues, as provided in this policy.
b. The Committee will review information provided by the Designated Official and will
make determinations as to the proper level of management of conflicts.
2. Conflicts of Interest in Decision Making.
a. A Committee member shall be recused from discussion of a particular case if:
1. The Committee member has a personal interest because of inter-departmental
relationships, such as collaboration with the faculty member whose case is under
consideration; or
2. The Committee member has a personal financial interest in the case under discussion.
K. PROCEDURES
1. Any instance of a potential conflict must be disclosed, and reduced, managed or eliminated
July 2012
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depending on the type and degree of conflict. It is the responsibility of each Employee to
disclose significant financial interest for review. It is the responsibility of the University to
evaluate and require the Employee to manage, reduce or eliminate the conflicts determined as
potential conflict of interest, specifically a Significant Financial Interest or Conflict of
Commitment. A monitoring plan will be established for every instance of using Federal funds and
private/corporate funds from a business entity as determined by the Conflict of Interest Committee.
a. Disclosure. This policy uses disclosure as the key mechanism to bring any interest to light
for further evaluation, and for oversight, where necessary.
1. Annual Disclosure. All Faculty and Key Personnel9 shall fill out an Annual Summary
of Outside Activities and Interests Form regarding the Employee’s, the Employee’s
Household or Family, and other Household or Family Members where the Employee
knows or should know of Significant Financial Interests that may pose a Potential
Conflict of Interest. This disclosure shall be submitted as part of the Employee’s Annual
employment evaluation. The Annual Summary of Outside Activities and Interests Form
shall be submitted to department chairs or directors who will keep all negative disclosures
in the employee’s personnel file and forward a copy of all positive disclosures in their unit
to the Designated Official at University of Nevada, Reno, 218 Ross Hall, Mail Code 0331.
2. Project Based Disclosure. If a Conflict arises during the year that was not disclosed on
the annual disclosure form due to a specific project, study, or technology proposal,
protocol or intellectual property disclosure that might be perceived as being in conflict
with external activities of the employee, the employee shall submit a Conflict Evaluation
Form directly to the Designated Official. The Principal Investigator shall indicate on a
Sponsored Projects transmittal form if there is any Faculty or other Employees included in
a proposal submission with a Significant Financial Interest or other potential conflict.
The Principal Investigator shall insure that any Employee with a potential conflict fills out
and submits a Conflict Evaluation Form. All Faculty and Key Personnel must
submit an ad hoc di sclosure of any si gni ficant financial interest they
acquire. If a new Conflict of Interest arises during the life of a project, a new Conflict
Evaluation Form must be submitted within 10 business days to the Principal Investigator
for forwarding to the appropriate administrative office.
3. Confidentiality and Reporting of Conflicts of Interest. All records and information
provided by an Employee for the purpose of disclosure and management and all official
records of disclosure and management shall be considered confidential. Any information
disclosed by an Employee as required by this policy shall be used solely for the purpose of
administering this policy and may not be used for any other purpose unless required by
law. Unauthorized disclosure of any such information by an Employee shall be deemed to
be unethical behavior and shall be subject to disciplined pursuant to appropriate
procedures. Board of Regents Policy requires that the University submit an annual report
of outside compensated professional or scholarly service that has been approved by the
University. The report will include aggregate data regarding p o s i t i v e disclosures
reviewed and approved under this policy. An employee may be required to publicly
disclose elements of a potential conflict of interest in his or her publications and/or
presentations if appropriate, applicable and required by the Conflict of Interest Committee
as part of a reasonable and appropriate management plan.
b. Review. Annual disclosures submitted to Department chairs and directors and project based
disclosures which identify a Significant Financial Interest or a potential Conflict of Interest will
of Purchasing as an ad-hoc member of the Committee for review of such disclosures. The
9
The chair/director of each University department may identify Employees whose positions do not require the
completion of an Annual Disclosure
July 2012
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Committee/designated official will determine by what means the conflict should be avoided or
be forwarded to the Designated Official who, will review the disclosures, gather more details if
necessary and forward the information for consideration to the Conflict of Interest Committee
(Committee).
To the extent that disclosures include procurement issues, the Designated
Official shall also forward the disclosures to the Director of Purchasing or include the Director
managed in order to mitigate undue bias.
In making those determination the
Committee/designated official will be guided by the principles discussed in this policy. The
Committee will review the file and make a determination that the potential conflict does not
require oversight, recommend a strategy for management and oversight of the potential
conflict, or recommend that the activity should not proceed. The final determination of the
Committee shall be provided, in writing, to the disclosing Employee and if appropriate, to
the Employee’s supervisor, chair, dean, or director. The Management, Monitoring and
Implementation plan and a statement of the University’s best interest regarding the
disclosed conflict will be forwarded to the President for final signature and approval.
c. Management and Oversight. The Committee will consider Significant Financial Interest or
Commitment of Interest as potential conflicts of interest(s) and determine whether to manage,
reduce or eliminate the conflict. The Committee, in consultation with the University Employee,
ultimately responsible for the proposed research or activity, will develop a Management,
Monitoring and Implementation Plan (the “Plan”). The Plan is subject to approval by the
Committee/Designated Official. A financial conflict of interest exists when the
Committee/Designated Official reasonably determines that the Significant
Financial Interest and/or a potential Conflict of Interest could directly and
significantly affect the conduct of the Employee. The Department Chair or Director of
the Employee with a potential Conflict of Interest will be responsible for providing process
and oversight for implementation of the Plan. All identified Significant Financial Interest or
Commitment of Interest must be handled by one of the following three approaches:
1. A conflict can be MANAGED if the conflict does not seem to be of such a degree that
the research or activity as proposed would be compromised in regards to academic
freedom, integrity or objectivity; or
2. The conflict must be REDUCED if there is a serious possibility that the research or
other activity as proposed would be compromised or a serious concern that there could be a
conflict with University policies.; or
3. The conflict must be ELIMINATED if the research or activity as proposed would be
compromised by the conflict. If the conflict cannot be eliminated, the Employee shall
eliminate the conflict by either divesting him/herself from all external financial interests or
by not proceeding with the research or activity.
d. Examples of conditions that might be imposed to manage a financial conflict of interest include
but are not limited to:
i) Public disclosure of financial conflicts of interest (e.g. when presenting or publishing
the research;
ii) For research projects involving human subjects research, disclosure of financial
conflicts of interest;
iii) Appointment of an independent monitor capable of taking measures to protect the
design, conduct, and reporting of the research against bias resulting from the financial
conflict of interest’
iv) Modification of the research plan
v) Change of personnel or personnel responsibilities, or disqualification of personnel from
July 2012
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e.
f.
g.
h.
participation in all or a portion of the research;
vi) Reduction or elimination of the financial interest (e.g. sale of an equity interest);
vii) Severance of relationships that create the financial conflicts;
viii)For research activity involving human subjects’ research, use of data and safety
monitoring boards;
ix) Double-blind conditions;
x) Provisions to conduct the work simultaneously at multiple sites;
xi) Written disclosure of the conflicts of interest to all individuals working on the research
study;
xii) Annual reports on the research progress to the Committee/Designated Official
No expenditures will be permitted until the Investigator has compiled with the Disclosure
requirements of this Policy and has agreed, in writing, to comply with any plans determined by
the Committee/Designated Official necessary to manage the conflict of interest. The
Committee/Designated Official will communicate with Office of Sponsored Projects, the
Dean’s office and any other appropriate official to notify of the existence and the nature of a
financial conflict of interest or Commitment of Interest and whether the conflict has been
managed, reduced or eliminated.
Coordination with other Offices. The Designated Official shall maintain a database of all
University personnel that provides information regarding when each individual submitted a
Financial Disclosure and the status of any Conflicts of Interests that have been identified. This
database will be accessible to the Office of Sponsored Programs Administration, the
Human Research Protection Office, and the Office of Technology Transfer.
Appeals. Appeals to any determination made by the Committee/Designated Official
shall be made to the Vice President for Research (for research matters) or to the Provost for all
other matters. The decision of the Vice President for Research or Provost on the appeal may
be appealed to the President of the University. The decision made on this appeal is final. In
conflict matters involving a Vice President, appeals shall be made to the President and his/her
decision on the appeal shall be final. Institutional Conflict of Interest appeals should be
addressed to the Executive Vice Chancellor for review and final decision.
Reporting. Procedures for internal and external reporting will be implemented by the
Designated Official
1.
Internal Reporting.
i) Annual Monitoring Plan reports, and any violations, will be submitted by the
Department Chair and Directors to the Designated Official, who will present them
to the Conflict of Interest Committee, and to the cognizant Vice Presidents as
appropriate.
ii) For proposals that may restrict disclosure of publication of students’ work that
constitutes a degree requirement are that will be the basis of evaluation of a student
(see Section E.1.b.1), initial disclosure shall also be routed to the Graduate School,
the Vice President for Students Services or other appropriate officials.
2. External Reporting
i)
The Public Health Service (“PHS”) requires that the University certify to the
PHS awarding component that action has been taken, prior to the institution’s
expenditure of any funds, to manage, reduce or eliminate any Conflict of
Interest.10 The University must specify the process that it will undertake to
10
PHS requires the University to certify that it will manage, reduce, or eliminate any new conflict of
interest, at least on an interim measure, within 60 days from the time that the conflict is identified.
July 2012
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ii)
iii)
manage, reduce, or eliminate the Conflict of Interest. See Section M in this policy.
The National Science Foundation requires that the University report any conflicts
of interest that cannot be, or have not been, satisfactorily managed, reduced or
eliminated. It is anticipated that other Federal agencies shall require similar
practices in t h e f u t u r e . These r e q u i r e m e n t s w i l l b e i n c o r p o r a t e d
i n t o t h i s p o l i c y a s requirements are imposed upon the University.
Prior to the expenditure of funds, University of Nevada, Reno will a) publish on a
publicly-accessible University of Nevada, Reno website or b) respond to any
requestor within 5 business days of the request, information concerning any
significant financial interest that meets the following criteria:
a) A significant financial interest was disclosed and is still held by the Employee;
b) A determination has been made that the Significant Financial Interest is related
to the PHS funded research; and c) A determination has been made that the
Significant Financial interest is a Financial Conflict of Interest or a potential
Conflict of Commitment.
This information to be made available shall be consistent with the requirements of
the PHS policy.
L. VIOLATIONS AND SANCTIONS
1. Reporting and Investigating.
a. The Designated Official will forward any reports of violations to the Committee and to
the Sponsoring Agency when specified by the agency policy, or contract or grant
requirements. The Committee will then forward a recommendation to the Vice President for
Research or other appropriate Vice President or the Provost as applicable. The cognizant Vice
President or Provost shall coordinate the investigation of any violation with any sponsor
who requires such investigation.
b. The cognizant Vice President or the Provost shall have the authority as appropriate to
determine resolution and discipline in accordance with NSHE Code or Nevada Administrative
Code for the reported violations. The Vice President for Research shall coordinate the
investigation of any violation with any sponsor who requires such investigation.
2. Discipline.
a. Violation of this University policy may result in discipline, including suspension and dismissal
as provided under any of the following University policies:
1. NSHE Code Chapter 6; and
2. Nevada Administrative Code.
b. Compliance with this policy may also be enforced through the exercise of administrative
responsibility for oversight of funded research and management of University facilities and
other University property. Such enforcement measures shall include, but shall not be limited to:
1. Freezing research funds or accounts;
2. Rescinding contracts entered in violation of this policy or state law; and/or
3. Bringing legal action to recover the amount of financial benefit received by an Employee as
a result of the Employee’s violation of this policy.
c. Violations of this Policy may also result in civil and criminal penalties pursuant to the
Nevada
Ethics in Government Law NRS Chapter 281 et seq. and may include prosecution for a felony.
d. The remedies provided or referenced above are cumulative and shall be deemed to include
any other remedies required or provided by applicable state or federal law.
July 2012
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e. Committee/Designated Official determines that a financial conflict of interest was not identified
or managed in a timely manner, including but not limited to an investigator’s failure to disclose
a significant financial interest that is determined to be a financial conflict of interest or failure
by an investigator to materially comply with a management plan for a financial conflict of
interest, the Committee/Designated Official will complete a retrospective review of the
investigator’s activities and the research study to determine whether the research conducted
during the period of non-compliance was biased in the design, conduct or reporting of the
research.
f. Documentation of the retrospective review shall include the project number, project title, name
of employee with the financial conflict of interest, reasons for the retrospective review, detailed
methodology used for the retrospective review and finding and conclusions of the review.
M. Conflict of Interest Involving Public Health Services Sub award
1.
The federal Public Health Services (PHS) has adopted regulations (42 CFR Part 50
subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations
describe the actions an individual and an organization must take in order to promote objectivity
in research. The regulations apply to all PHS funded grants, cooperative agreements, research
contracts (but not Phase 1 Small Business Innovations Research or Small Business Technology
Transfer program grants) and sub awards where the originating sponsor is PHS.
a. DEFINITIONS
“Clinical Trial” means any research study that involves interaction with human subjects and
the concurrent investigative use of drugs, biologics, devices or medical or other clinical
procedures, such as surgery.
“Conflict of Interest Committee (Committee)” means the Institution’s committee or individual
that advises the Institutional Official on conflict of interest matters.
“Family” means any member of the Investigator’s immediate family, specifically, any dependent
children and spouse or domestic partner.
“Financial Interest” means anything of monetary value received or held by an Investigator or
an Investigator’s Family, whether or not the value is readily ascertainable, including, but not
limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid
authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or
other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks,
service marks, and copyrights), upon receipt of royalties or other income related to such
intellectual property rights and interests.
Financial Interest does NOT include:
a) salary, royalties, or other remuneration from the Institution;
b) income from the authorship of academic or scholarly works;
c) income from seminars, lectures, or teaching engagements sponsored by or from advisory
committees or review panels for U.S. Federal, state or local governmental agencies; U.S.
institutions of higher education; U.S. research institutes affiliated with institutions of higher
July 2012
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education, academic teaching hospitals, and medical centers; or
d) equity interests or income from investment vehicles, such as mutual funds and retirement
accounts, so long as the Investigator does not directly control the investment decisions made
in these vehicles.
For Investigators, Financial Interest also includes any reimbursed or sponsored travel undertaken
by the Investigator and related to his/her institutional responsibilities. This includes travel that is
paid on behalf of the Investigator rather than reimbursed, even if the exact monetary value is not
readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local
governmental agencies, U.S. institutions of higher education, research institutes affiliated with
institutions of higher education, academic teaching hospitals, and medical centers.
“Significant Financial Interest (SFI)” means a Financial Interest that reasonably appears to be
related to the Investigator’s Institutional Responsibilities, and:
i) if with a publicly traded entity, the aggregate value of any salary or other payments
for services received during the 12 month period preceding the disclosure, and the
value of any equity interest during the 12 month period preceding or as of the date of
disclosure, exceeds $5,000; or
ii) if with a non-publicly traded entity, the aggregate value of any salary or other
payments for services received during the 12 month period preceding the disclosure
exceeds $5,000; or
iii) if with a non-publicly-traded company, is an equity interest of any value during the 12
month period preceding or as of the date of disclosure; or
iv) if income related to intellectual property rights and interests not reimbursed through
the Institution.
“Financial Conflict of Interest” means a significant financial interest (or, where the
Institutional official requires disclosure of other Financial Interests,) that the Institution
reasonably determines could directly and significantly affect the design, conduct or reporting of
Institutional research.
“Institutional official” means the individual within the Institution that is responsible for the
solicitation and review of disclosures of significant financial interests including those of the
Investigator’s Family related to the Investigator’s institutional responsibilities. For the purposes
of this policy, the Institutional Official is designated as Vice President for Research.
“Institutional responsibilities” means the Investigator’s responsibilities associated with his or
her Institutional appointment or position, such as research, teaching, clinical activities,
administration, and institutional, internal and external professional committee service.
“Investigator” means any individual who is responsible for the design, conduct, or reporting of
Public Health Service (PHS) sponsored research, or proposals for such funding. This definition
is not limited to those titled or budgeted as principal investigator or co-investigator on a
particular proposal, and may include postdoctoral associates, senior scientists, or graduate
students. The definition may also include collaborators or consultants as appropriate.
July 2012
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“Public Health Service (PHS)” means the Public Health Service of the U.S. Department of
Health and Human Services, and any components of the PHS to which the authority of the PHS
may be delegated. The components of the PHS include, but are not limited to, the Administration
for Children and Families, Administration on Aging, Agency for Healthcare Research and
Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and
Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and
Services Administration, Indian Health Service, National Institutes of Health, and Substance
Abuse and Mental Health Services Administration.
“Research” means a systematic investigation, study, or experiment designed to contribute to
generalizable knowledge relating broadly to public health, including behavioral and socialsciences research. The term encompasses basic and applied research (e.g., a published article,
book or book chapter) and product development (e.g., a diagnostic test or drug).
b. Disclosure
1. The regulations require that investigators submitting applications for funding as a subrecipient, where the prime sponsor is PHS (e.g. funding from the National Institute of
Health, the Food and Drug Administration, the center for Disease Control), prior to the
submission of the sub award application the PHS grantee organization, disclose to Conflict
of Interest Committee any significant financial interests related to their responsibilities.
2. Prior to the submission of an application to the PHS Grantee for funding, the Investigator
and all other investigators must have disclosed to the Conflict of Interest Committee or
Designated Official an up-to- date listing of their significant financial interests (SFI) and
those of their spouse or domestic partner and dependent children, as defined in Section K of
this policy.
3. Any new investigator, who subsequent to the submission of an application to the PHS
Grantee for funding from the PHS Grantee, or during the course of the research project,
plans to participate in the project, must similarly disclose their significant financial interest
to the Committee/Designated Official promptly and prior to participation in the project.
4. Each investigator who is participating in research under a sub award where the prime
award originates from PHS must submit an updated disclosure at least annually, during the
period of the award. Such disclosure must include any information that was not disclosed
initially, pursuant to this policy, or in a subsequent disclosure of SFI on a PHS funded
project directly as a PHS Grantee and/or indirectly through a sub award that was transferred
from another institution, and must include updated information regarding any previously
disclosed significant financial interest or potential conflict of interest.
5. Each investigator who is participating in research under a sub award where the prime
award originates from PHS must submit an updated disclosure of significant financial
interest within 30 days of discovering or acquiring a new significant financial interest.
6. The Committee/Designated Official will determine whether an Investigator’s significant
financial interest (SFI) is related to the research under a sub award supported by a PHS
July 2012
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prime award and if so, whether the significant financial interest (SFI) is a financial conflict
of interest. An Investigator’s significant financial interest (SFI) is related to the research
under the sub award when the Committee/Designated Official reasonably determines that 1)
the significant financial interest (SFI) could be affected by the research conduct under the
sub award; or 2) is in an entity whose financial interest could be affected by the research;
3)The role of the investigator and 4) the opportunity to bias the results, 5)the nature of the
research being proposed, and 6) the value of the significant financial interest (SFI) in
relation to the size and value of the entity. The Committee/Designated Official may involve
the investigator in the determination of whether a significant financial interest (SFI) is
related to the research supported sub award. These interests will be compared to each
research sub award in which the Employee is identified as responsible for the design,
conduct or reporting of the research to determine if a significant financial interest (SFI) is
related to the award and, if so, whether the significant financial interest (SFI) creates a
conflict of interest related to the award. The Committee/Designated Official will also take
into consideration whether the investigator’s ongoing role is necessary to continue
advancing the research, based upon the factors such as the uniqueness of his or her expertise
and qualifications.
7. Investigators must disclose reimbursed or sponsored travel related to their institutional
responsibilities. Such disclosures must include, at a minimum, the purpose of the trip, the
identity of the sponsor/organizer, the destination, the duration and if know the monetary
value. The Committee/Designated Official will determine if additional information is
needed (e.g. the monetary value if not already disclosed) to determine whether the travel
constitutes a financial conflict of interest with the Investigator’s research.
8. Each Investigator must complete training prior to engaging in research funded by PHS
and at least every four years thereafter. The training must be completed within a reasonable
period of time as determined by the Committee/Designated Official. Or, if it has been
determined that the Investigator has not complied with this policy or with a management
plan related to their activities. Training requirements of the CITI module, entitled COI Mini
Course, on Conflict of Interest policy and regulations will be required. Access to CITI may
be accessed on UNR web site at several locations with URL and instructions; specifically go
to URL https://www.citiprogram.org/default.asp
9. Committee/Designated Official will update any previously submitted report to the PHS or
the prime PHS-awardee relating to the research, specifying the actions that will be taken to
manage the financial conflict of interest going forward. If bias is found, the report will
include a mitigation report in accordance with the PHS regulations, including a description
of the impact of the bias on the research project and the plan of action to eliminate or
mitigate the effect of bias.
N. FORCE OF LAW
This policy shall be deemed to include all requirements relating to conflicts of interest to which the
University and University Employees are subject under state or federal law.
O. REVISIONS
Revisions may be made to this policy when otherwise appropriate or necessary and shall be submitted
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to the Administrative Manual Committee for review and approval and then submitted to the President
for approval.
P. REFERENCES
1. Administrative Manual Policies and Procedures Section 1,505 — Conflict of Interest Prohibited.
2. Administrative Manual Policies and Procedures Section 1,525 — Personal Use of University
Property or Resources.
3. Administrative Manual Policies and Procedures Section 2,370 to 2,373 — Disciplinary Actions and
Dismissal of Staff Employees.
4. Administrative Manual Policies and Procedures Section 2,690 — Consulting Services and Conflict of
Interest.
5. Administrative Manual Policies and Procedures Section 4,320 — Appropriate Use of
Computer Facilities.
6. Administrative Manual Policies and Procedures Section 5,302 to 5,304 — Policy for Use of
University Space.
7. Administrative Manual Policies and Procedures Section 5,400 — Use and Security of Property.
8. Administrative Manual Policies and Procedures Section 6,503 and 6,507 — Patent and Copyright
Policy: Ownership Purpose and Scope.
9. Administrative Manual Policies and Procedures Section 6,510 — Use of Human Subjects.
10. Administrative Manual Policies and Procedures Section 6,515 — Ethical Standards in Conduct of
Research.
11. Anti-Kickback Act of 1986 (41 U.S.C. 51-58) and OMB A-110.
12. National Science Foundation Policy, Grant Policy Manual 510, Investigator Disclosure Policy, 60
F.R.132, pp. 35810-823 (July 11, 1995).
13. Nevada Administrative Code Chapter, chapters 122A, 284.
14. Nevada Criminal Code.
15. Nevada Public Officers’ and Employees’ Ethics Act, NRS. 281.
16. Nevada Revised Statutes 281.481 – 281.581.
17. NSHE Business Office North Purchasing Policy.
18. NSHE Code Chapter 6 — Rules and Disciplinary Procedures for Members of the
University Community.
19. NSHE Purchasing Code — Restricted Purchases and Special Procurement.
20. NSHE Purchasing Code — Procurement from Vendor, University Employee with Interest.
21. NSHE Regents Handbook Title 4.1.11 — Personal Use of University Property or Resources.
22. NSHE Regents Handbook Title 4 Chapter 3 Section 8 – Compensated Outside Professional Services.
23. UNR Additional Compensation and Overload Policy (“LOA” contracts).
24. U.S. Department of Health and Human Services, Objectivity in Research Subpart F —
Responsibility of Applicants for Promoting Objectivity in Research for Which Funding is Sought,
42 CFR Part 50, Subpart F. and 45 CFR 94
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